The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
Charleston, South Carolina, United States
Frequency of arrhythmias between baseline and 3-months
Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at \>120 beats per minute \[BPM\] ) plus arrhythmias detected by the ICD
Time frame: 3-months
Frequency of arrhythmias between 3-months and 9-months
Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at \>120 BPM ) plus arrhythmias detected by the ICD
Time frame: 9-months
Frequency of ICD therapies between baseline and 3-months
Obtained from ICD interrogation reports from recording between baseline and 3-months
Time frame: 3-months
Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time frame: 3-months
Frequency of ICD therapies between 3-months and 9-months
Obtained from ICD interrogation reports between 3- and 9-months
Time frame: 9-months
Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months
Index of parasympathetic activity; obtained from 24-hour Holter recording
Time frame: 9-months
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